Designing and building a new clean room facility, or installing new equipment, is a stressful occupation. Let us help you ease the load by compiling your Validation Master Plan, User Requirement Specification, Design Qualification and any other documents in conjunction with yourselves and your selected contractors.
We can also carry out validation work including temperature mapping in refrigerators and small warehouses.
Projects completed:
Company A in the North of England needed a Performance Qualification strategy and protocol for a large isolator suite. Spheriqual Ltd worked with their Project Manager and QA staff to deliver the requirements within the timescales specified.
Company B in the East of England required a Validation Master Plan and a set of installation, operation and performance qualification documents for a range of equipment in their new small-scale manufacturing suite. Spheriqual Ltd were involved throughout the project from the beginning, supplying the validation documents, Standard Operating Procedures and training materials, and assisted the company through a successful inspection.
Company C in London installed a cold store in their warehouse so that they could start importing cold chain goods. Spheriqual Ltd advised on design and location, supplied the documents and carried out a range of qualification activities including temperature mapping, leading to approval of the facility for its intended purpose.